BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM

    MDR report key: 2760652 · Received September 26, 2012

    Report

    Report Number
    2183870-2012-00187
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    August 28, 2012
    Report Date
    August 28, 2012
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. EVAL SUMMARY: DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    THE PHYSICIAN TRIED TO PUSH THE VISI-PRO STENT THOUGH THE PROXIMAL PORTION OF THE LESION AFTER PREDILATATION WITH A 5MM BALLOON. THE STENT WOULD NOT GO THROUGH. WHEN REMOVING THE STENT, THE PHYSICIAN NOTICED THAT THE VISI-PRO STENT HAD BEEN DISLODGED. THE PHYSICIAN PROCEEDED TO USE A SNARE TO SUCCESSFULLY EXTRACT STENT. NO INJURY TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISI-PRO¿ BALLOON-EXPANDABLE BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PXB35-07-27-080 9489803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention